ISO 22716 is what GMP looks like when applied to cosmetics. It is structurally similar to dietary supplement cGMP but tailored to the realities of cosmetics production: lower-risk product profile, broader ingredient flexibility, different sanitation requirements, longer shelf-life expectations.

What it covers: personnel training and hygiene, premises and equipment, raw material control, production processes, finished product control, deviations and complaints, change control, internal audits, and contracted activities. The standard is product-focused — it cares about how the product is made, traceability, and consistency.

The EU requires ISO 22716 compliance for cosmetics manufacturing under EU Regulation 1223/2009. Any cosmetics product sold in the EU must come from a facility that demonstrably meets ISO 22716. The U.S. has historically had a looser cosmetics GMP framework, but MoCRA (2022) is closing that gap and pushing U.S. manufacturers toward ISO 22716 as the practical standard.

Certification is achieved through a third-party audit by a recognized certification body (SGS, Bureau Veritas, NSF, TÜV). Certificates expire annually and require surveillance audits. The cost of initial certification ranges $8,000-25,000 per facility depending on size.